Efficacy and Safety of Rimonabant With or Without Hypocaloric Diet in Obese Patients
Phase 3
Completed
- Conditions
- Obesity
- Registration Number
- NCT00481923
- Lead Sponsor
- Sanofi
- Brief Summary
The primary objective of this study is to assess the effect of rimonabant on the energy intake (kcal/day/meal) from ad-libitum high-fat dinner (primary endpoint), pre- and post-ingestive responses, and the hedonic evaluation of food, and its effect on food choice, cravings and feelings of control.
The secondary objectives are to determine the effect of rimonabant on body weight with or without hypocaloric diet and its clinical and laboratory safety.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 156
Inclusion Criteria
- Obese subjects with Body Mass Index ≥ 30 and < 45 kg/m²
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Absolute change from baseline in energy intake during ad-libitum dinner of the high-fat probe day at Weeks 3/4 of double-blind treatment.
- Secondary Outcome Measures
Name Time Method Satiety, food choice, feeling of control, craving using a series of rating scales during the probe and/or "free-living" days Clinical Safety
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇬🇧Guilford, United Kingdom